# US 12,214,157 B2 · Fluid interface device for delivering fluid to and/or withdrawing fluid from a patient > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 12,214,157 B2 - Document ID: US12214157B2 - Status: Granted - Kind: B2 - Application number: 17/465,880 - Filed: 2021-09-03 - Published: 2022-02-24 - Granted: 2025-02-04 - Earliest claimed: 2015-12-11 - Assignees: SeraIP AG - Applicants: SeraIP AG - Inventors: Carlo Andretta - Web page: https://patentgrep.com/patent/US12214157B2 ## CPC - A61M 5/14276: {specially adapted for implantation} - A61B 5/157: {Devices} characterised by integrated means for measuring characteristics of blood - A61M 5/1723: {using feedback of body parameters, e.g. blood sugar or pressure} - A61M 39/0208: {Subcutaneous access sites (implantable infusion devices A61M5/14276; transcutaneous access sites A61M39/0247)} - A61M 39/10: Tube connectors or tube couplings - A61B 5/15003: {for venous or arterial blood} - A61M 2039/0276: {for introducing or removing fluids into or out of the body} - A61M 2230/201: Glucose concentration - A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)} - A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D) ## Abstract A fluid interface device for delivering fluid to and/or withdrawing fluid from a patient, the device comprises a peripheral base element (2) and a fluid transmission element (4) sealingly connected to the base element and forming a central portion of the device. The fluid transmission element comprises a front platelet (6) with a primary face (8) and a secondary face (10) opposed thereto, the primary face being in contact with a patient's body fluid region (12) when the device is implanted in the patient, the fluid transmission element further comprising a counterplate (14) sealingly stacked against the secondary face of the front platelet and forming a buffer volume (16) therebetween. The front platelet comprises at least one array of microchannels (18) defining a fluid passage between the buffer volume and the primary face, the microchannels having an opening of 0.2 to 10 μm. The counterplate has at least one fluid port (20; 20a, 20b) for fluid delivery to and/or fluid withdrawal from the buffer volume. ## Claims ### Claim 1 A fluid interface device for delivering fluid to and/or withdrawing fluid from a body of a patient, the device comprising: a peripheral base element; a fluid transmission element forming a central portion of the device and being sealingly connected to the peripheral base element which is circumferentially arranged around the fluid transmission element, the fluid transmission element comprising a front platelet with a primary face and a secondary face opposed to the primary face, the primary face being in contact with a patient's body fluid region when the device is implanted into the body of the patient, the fluid transmission element further comprising a counterplate sealingly stacked against the secondary face of the front platelet and forming a buffer volume therebetween; the front platelet comprising at least one array of microchannels defining a fluid passage between the buffer volume and the primary face, each of the microchannels is a circular microchannel or a non-circular microchannel, wherein each of the circular microchannels has a diameter of 0.6 μm to 2 μm and each of the non-circular microchannels has a smallest transversal size of 0.6 μm to 2 μm; the fluid transmission element having at least one fluid port for fluid delivery to and/or fluid withdrawal from the buffer volume, wherein the primary face is provided with guard elements protruding with respect to a plane defined by microchannel exits located in the primary face, the guard elements being formed in such manner as to define at least one transversal limitation over each microchannel exit, the transversal limitation being larger than, for each of the circular microchannels, the diameter of each of the circular microchannels and, for each of the non-circular microchannels, the smallest transversal size of each of the non-circular microchannels and being in the range of 2 μm to 4 μm. ### Claim 2 (depends on 1) The fluid interface device according to claim 1, wherein the at least one fluid port comprises at least two fluid ports. ### Claim 3 (depends on 2) The fluid interface device according to claim 2, wherein each fluid port is arranged in the counterplate. ### Claim 4 (depends on 1) The fluid interface device according to claim 1, wherein the front platelet is made of Si and/or Si3N4, and wherein the counterplate is made of glass. ### Claim 5 (depends on 1) The fluid interface device according to claim 1, wherein the front platelet and the counterplate are joined to each other by anodic bonding. ### Claim 6 (depends on 1) The fluid interface device according to claim 1, wherein the fluid transmission element and the base element are sealingly connected to each other via a ridge structure surrounding the fluid transmission element, the ridge structure being made of a biocompatible thermoplastic formed around the fluid transmission element by injection molding. ### Claim 7 (depends on 6) The fluid interface device according to claim 6, wherein the peripheral base element is sealingly connected to the ridge structure by injection molding thereon a covering part or by ultrasonic welding. ### Claim 8 (depends on 6) The fluid interface device according to claim 6, wherein the peripheral base element is formed as a foamed pad of a thermoplastic fluoropolymer which is suitable for implantation in a patient's blood vessel wall, and wherein the injection molded ridge structure is formed as a non-foamed body of said thermoplastic fluoropolymer. ### Claim 9 (depends on 1) The fluid interface device according to claim 1, wherein the peripheral base element is formed as a rigid frame structure suitable for fixation to an osseous structure of a patient. ### Claim 10 (depends on 1) The fluid interface device according to claim 1, which is configured as an elongated body having a proximal end, a distal end and a lateral surface therebetween, the front platelet of the fluid transmission element being disposed to form part of the lateral surface. ### Claim 11 (depends on 10) The fluid interface device according to claim 10, wherein the distal end of the elongated body has a pointed shape. ### Claim 12 (depends on 10) The fluid interface device according to claim 10, wherein the elongated body is provided with a longitudinal passage extending from the distal end to the proximal end. ### Claim 13 (depends on 10) The fluid interface device according to claim 10, wherein the peripheral base element forms an outer sheath of the elongated body. ### Claim 14 (depends on 10) The fluid interface device according to claim 10, wherein the front platelet and the counterplate are made of Si and/or Si3N4. ### Claim 15 (depends on 10) The fluid interface device according to claim 10, wherein the buffer volume comprises a single compartment being in connection with a respective microchannel array and one of the at least one fluid port. ### Claim 16 (depends on 10) The fluid interface device according to claim 10, wherein the at least one fluid port comprises two fluid ports and wherein the buffer volume comprises a single compartment being in connection with a respective microchannel array and the two fluid ports. ### Claim 17 (depends on 10) The fluid interface device according to claim 10, wherein the buffer volume comprises two separate compartments, each compartment being in connection with a respective microchannels array and a respective fluid port. ### Claim 18 (depends on 17) The fluid interface device according to claim 17, wherein the two separate compartments are arranged at one side of the elongated body. ### Claim 19 (depends on 10) The fluid interface device according to claim 10, wherein the at least one fluid port comprises two fluid ports and wherein the buffer volume comprises two separate compartments, each compartment being in connection with a respective microchannels array and the two fluid ports. ### Claim 20 (depends on 10) The fluid interface device according to claim 10, wherein the elongated body comprises for each fluid port of the at least one fluid port a fluid passage leading to a channel opening at the proximal end of the elongated body. ### Claim 21 (depends on 20) The fluid interface device according to claim 20, wherein said proximal end is provided with means for attaching a fluid supply connector to each one of said channel openings. ### Claim 22 (depends on 1) The fluid interface device according to claim 1, wherein the peripheral base element is configured as a wall section of a tubular segment suitable for containing a patient's body fluid. ### Claim 23 (depends on 22) The fluid interface device according to claim 22, wherein the fluid transmission element and the base element are sealingly connected to each other by means of a ridge structure surrounding the fluid transmission element, the ridge structure being made of a biocompatible thermoplastic formed around the fluid transmission element by injection molding, and wherein the peripheral base element is integrally formed on the tubular segment which is also made of the biocompatible thermoplastic. ### Claim 24 (depends on 22) The fluid interface device according to claim 22, wherein the tubular segment is provided at both ends thereof with means for connecting to a patient's systemic circuit. ### Claim 25 (depends on 1) A system for delivering fluid to and/or withdrawing fluid from a patient's body region, the system comprising the fluid interface device according to claim 1, fluid storage means and fluid transfer means for controlled fluid delivery to and fluid withdrawal from the buffer volume via the at least one fluid port, the system being configured to be able to perform at least the following steps according to a pre-defined step sequence: a) running flushing medium through the buffer volume; b) running flushing medium through the at least one microchannels array; c) withdrawing patient's body fluid through the at least one microchannels array; and d) delivering a therapeutic agent to the patient. ### Claim 26 (depends on 25) The system according to claim 25, wherein the fluid transfer means are configured as transdermal tubing. ### Claim 27 (depends on 25) The system according to claim 25, wherein the fluid transfer means comprise: a subcutaneously implantable injection port having at least one injection chamber, each injection chamber having an upper inlet opening covered by a pierceable septum and an exit opening; at least one fluid transfer line having a first and a second end connectable at the first end to said exit opening and connectable at the second end to a corresponding fluid port of said fluid interface device. ### Claim 28 (depends on 25) The system according to claim 25, further comprising means for establishing a continuous or intermittent flow of supply medium through the buffer volume, whereby a fraction of supply medium is delivered to the patient through the fluid transmission element. ### Claim 29 (depends on 25) A method of operating the system according to claim 25, in which method a flushing medium is delivered to the buffer volume so as to maintain an overpressure relative to a base pressure in the patient's body region when the system is not withdrawing patient's body fluid or delivering a therapeutic agent to the patient, thereby preventing any flow from the patient's body region through the microchannels into the buffer volume. ### Claim 30 (depends on 1) A method for delivering fluid to and/or withdrawing fluid from a patient's body region, comprising: providing the fluid interface device of claim 1, which is part of a system also comprising fluid storage means and fluid transfer means for controlled fluid delivery to and fluid withdrawal from the buffer volume via the at least one fluid port, delivering a flushing medium to the buffer volume, whereby an overpressure relative to a base pressure in the patient's body region when the system is not withdrawing patient's body fluid or delivering a therapeutic agent to the patient is maintained and, thereby preventing any flow from the patient's body region through the microchannels into the buffer volume, and withdrawing the fluid/the patient's body fluid from the patient's body region through the at least one microchannels array and/or delivering the fluid/the therapeutic agent to the patient. ### Claim 31 A fluid interface device for delivering fluid to and/or withdrawing fluid from a body of a patient, the device comprising: a peripheral base element; a fluid transmission element forming a central portion of the device and being sealingly connected to the peripheral base element which is circumferentially arranged around the fluid transmission element, the fluid transmission element comprising a front platelet with a primary face and a secondary face opposed to the primary face, the primary face being in contact with a patient's body fluid region when the device is implanted into the body of the patient, the fluid transmission element further comprising a counterplate sealingly stacked against the secondary face of the front platelet and forming a buffer volume therebetween; the front platelet comprising at least one array of microchannels defining a fluid passage between the buffer volume and the primary face, each of the microchannels is a circular microchannel or a non-circular microchannel, wherein each of the circular microchannels has a diameter of 0.2 μm to 10 μm and each of the non-circular microchannels has a smallest transversal size of 0.2 μm to 10 μm; the fluid transmission element having at least one fluid port for fluid delivery to and/or fluid withdrawal from the buffer volume, wherein (i) the counterplate is substantially planar and wherein the buffer volume is enclosed within a peripheral protrusion zone of the secondary face of the front platelet, and/or (ii) the buffer volume comprises at least two separate compartments, each compartment being in connection with a respective microchannel array and the at least one fluid port. ### Claim 32 (depends on 31) The fluid interface device according to claim 31, wherein the buffer volume comprises the at least two separate compartments of (ii). ### Claim 33 (depends on 31) The fluid interface device according to claim 31, wherein the counterplate is substantially planar and wherein the buffer volume is enclosed within the peripheral protrusion zone of the secondary face of the front platelet. ### Claim 34 A fluid interface device for delivering fluid to and/or withdrawing fluid from a body of a patient, the device comprising: a peripheral base element; a fluid transmission element forming a central portion of the device and being sealingly connected to the peripheral base element which is circumferentially arranged around the fluid transmission element, the fluid transmission element comprising a front platelet with a primary face and a secondary face opposed to the primary face, the primary face being in contact with a patient's body fluid region when the device is implanted into the body of the patient, the fluid transmission element further comprising a counterplate sealingly stacked against the secondary face of the front platelet and forming a buffer volume therebetween; the front platelet comprising at least one array of microchannels defining a fluid passage between the buffer volume and the primary face, each of the microchannels is a circular microchannel or a non-circular microchannel, wherein each of the circular microchannels has a diameter of 0.2 μm to 10 μm and each of the non-circular microchannels has a smallest transversal size of 0.2 μm to 10 μm; the fluid transmission element having at least two fluid ports for fluid delivery to and/or fluid withdrawal from the buffer volume, each fluid port being arranged in the counterplate, the fluid interface device further comprising a spacer element made of a thermoplastic polymer, the spacer element having a first spacer face that is adhesively connected to an external face of the counterplate, the spacer element comprising traversing channels connecting the first spacer face and a second spacer face, each traversing channel being arranged to form a passage between one of the fluid ports and a corresponding channel opening at the second spacer face. ### Claim 35 (depends on 34) The fluid interface device according to claim 34, further comprising a fluid supply connector and means for releasably attaching the fluid supply connector to the spacer element, the fluid supply connector comprising connector channels each leading from a lateral entrance port to an exit port coinciding with a channel opening at the second spacer face when the fluid supply connector is attached to the spacer element. ### Claim 36 (depends on 35) The fluid interface device according to claim 35, wherein each one of said connector channels is formed as a pair of grooves in adjacent faces of mutually contacted connector parts. ### Claim 37 (depends on 34) The fluid interface device according to claim 34, further comprising a fluid supply connector attached to the spacer element, the fluid supply connector comprising connector channels each leading from an entrance port to an exit port coinciding with a channel opening at the second spacer face, the fluid supply connector being configured as a sealing mass that encapsulates the spacer element and the fluid transmission element and furthermore forms the peripheral base element.